An Open-label, Ascending, Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA)

Investigating Dosing for a Joint Condition in Children and Adolescents

Not Recruiting
2 years - 17 years
All
Phase 2
102 participants needed

Study Overview

Primary Objective:

To describe the pharmacokinetic (PK) profile of sarilumab in participants aged 2-17 years with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) in order to identify the dose and regimen for adequate treatment of this population

Secondary Objective:

To describe the pharmacodynamic (PD) profile, the efficacy and the long-term safety of sarilumab in participants with pcJIA.

Study Details

For 73 participants enrolled in the dose-finding and second portions, the total study duration per participant was up to 166 weeks that consists of a 4- week screening, a 12-week core treatment phase, a 144-week extension phase, and a 6-week post-treatment follow-up. For 29 participants enrolled in the third portion, the total study duration per participant was up to 106 weeks that consists of a 4- week screening, a 12-week core treatment phase, a 84-week extension phase, and a 6-week post-treatment follow-up.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Juvenile Idiopathic Arthritis
  • Age: 2 years - 17 years
  • Gender: All

Inclusion criteria :

  • Male and female participants aged ≥2 and ≤17 years (or country specified age requirement) at the time of the screening visit.
  • Diagnosis of rheumatoid factor-negative or rheumatoid factor positive polyarticular Juvenile Idiopathic Arthritis (JIA) subtype or oligoarticular extended JIA subtype according to the International League of Associations for Rheumatology (ILAR) 2001 Juvenile Idiopathic Arthritis Classification Criteria with at least 5 active joints as per American College of Rheumatology (ACR) definition for "active arthritis" at Screening
  • Participant with an inadequate response to current treatment and considered as a candidate for a biologic disease modifying antirheumatic drug (DMARD) as per investigator's judgment

Exclusion criteria:

  • Body weight <10 kg or >60 kg for participants enrolled in the 3 ascending dose cohorts, then body weight <10 kg for participants subsequently enrolled at the selected dose-regimen.
  • If nonsteroidal anti-inflammatory drugs (NSAIDs) [including cyclo oxygenase-2 inhibitors (COX-2)] taken, dose stable for <2 weeks prior to the baseline visit and/or dosing prescribed outside of approved label.
  • If non-biologic DMARD taken, dose stable for <6 weeks prior to the baseline visit or at a dose exceeding the recommended dose as per local labeling.
  • If oral glucocorticoid taken, dose exceeding equivalent prednisone dose 0.5 mg/kg/day (or 30 mg/day) within 2 weeks prior to baseline.
  • Use of parenteral or intra-articular glucocorticoid injection within 4 weeks prior to baseline.
  • Prior treatment with anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab.
  • Treatment with any biologic treatment for pcJIA within 5 half-lives prior to the first dose of sarilumab.
  • Treatment with a Janus kinase inhibitor within 4 weeks prior to the first dose of sarilumab; and treatment with growth hormone within 4 weeks prior to the first dose of sarilumab (the required off treatment periods and procedures may vary according to local requirements).
  • Treatment with any investigational biologic or non-biologic product within 8 weeks or 5 half-lives prior to baseline, whichever is longer.
  • Lipid lowering drug stable for less than 6 weeks prior to screening.
  • Exclusion related to tuberculosis (TB).
  • Exclusion criteria related to past or current infection other than tuberculosis.
  • Any live, attenuated vaccine within 4 weeks prior to the baseline visit, such as varicella-zoster, oral polio, rubella vaccines. Killed or inactive vaccine may be permitted based on the Investigator's judgment.
  • Exclusion related to history of a systemic hypersensitivity reaction to any biologic drug and known hypersensitivity to any constituent of the product.
  • Laboratory abnormalities at the screening visit (identified by the central laboratory).
  • Pregnant or breast-feeding female adolescent participants.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

This study investigates the dosing and effects of an investigational medication in children and adolescents aged 2 to 17 years with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA). The purpose of this study is to understand how the investigational medication is processed in the body, which is known as its pharmacokinetic profile, to determine the appropriate dose and regimen for treating this condition.

Participants in the study will receive repeated doses of the investigational medication. The study will look at how the medication affects the body (pharmacodynamics), its effectiveness, and its long-term safety. Participants will undergo various medical assessments to monitor their response to the treatment and ensure their safety throughout the study.

  • Who can participate: Eligible participants are children and adolescents aged 2 to 17 years diagnosed with polyarticular-course Juvenile Idiopathic Arthritis with at least 5 active joints. They must have an inadequate response to current treatments and be considered candidates for biologic disease-modifying drugs. Participants must weigh between 10 kg and 60 kg for certain study parts.
  • Study details: Participants will receive doses of the investigational medication and undergo regular assessments to monitor their response and safety. A placebo, an inactive substance that looks like the investigational medicine but does not contain any medicine, is not used in this study.
Updated on 24 Oct 2024. Study ID: NCT02776735